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Except as set forth below, there have been no material changes from the risk factors previously disclosed in our annual report on Form 10-K for the year ended December 31, 2025, as filed with the SEC.
−Removed: We are subject to Nasdaq's continued listing requirements.
−Removed: We have in the recent past failed to satisfy one or more of the requirements, and if we fail to satisfy one or more of the requirements in the future, we may be delisted from Nasdaq.
+Added: We are not currently in compliance with Nasdaq ’ s continued listing requirements related to the bid price of our common stock and if we are unable to regain compliance with the listing requirements, our common stock will be delisted from Nasdaq which could have a material adverse effect on our financial condition and could make it more difficult for stockholders to sell their shares.
Our common stock is listed on Nasdaq, and we are therefore subject to its continued listing requirements, including requirements with respect to the market value of publicly held shares, market value of listed shares, minimum bid price per share, and minimum stockholder’s equity, among others, and requirements relating to board and committee independence.
If we fail to satisfy one or more of the requirements, we may be delisted from Nasdaq.
−Removed: During 2025, we received notices that we were not in compliance with Nasdaq Listing Rule 5550(b)(1) (the “Equity Rule”), which requires that we maintain a minimum of $2.5 million in stockholders’ equity, and Nasdaq Listing Rule 5550(a)(2), which related to the bid price for our common stock being below the minimum $1.00 per share (the “Bid Price Rule”).
−Removed: On December 15, 2025, we received a letter from Nasdaq confirming that we had regained compliance with the Bid Price Rule because the closing bid price of the Company’s common stock was $1.00 per share or greater for the 10 consecutive business days from December 1, 2025, through December 12, 2025.
−Removed: On January 6, 2026, we received notice that we had regained compliance with the Equity Rule and that the Company was in compliance with all applicable continued listing standards.
−Removed: Although we are currently in compliance with all Nasdaq continued listing standards, there is no assurance that we will be able to maintain such compliance in the future.
+Added: Since July 31, 2026, the closing price of our common stock has been below $1.00, and if our common stock remains below $1.00 for 30 consecutive business days we will not be in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).
+Added: In accordance with Nasdaq rules, we would normally be provided with a grace period of 180 calendar days to regain compliance with the Bid Price Rule.
+Added: However, since we completed a reverse stock split on December 1, 2025, which is within the last one-year period, if we do not meet the Bid Price Rule, we will not be eligible for any compliance period and the Nasdaq Staff will provide written notification to us that our common stock may be delisted.
+Added: We would then be entitled to appeal the Staff’s determination to a Nasdaq Listing Qualifications Panel and request a hearing.
+Added: There can be no assurance that, if we do appeal the delisting determination by the Staff to the Nasdaq Listing Qualifications Panel, that such appeal would be successful.
Delisting from Nasdaq would adversely affect our ability to raise additional financing through the public or private sale of equity securities, may significantly affect the ability of investors to trade our securities and may negatively affect the value and liquidity of our common stock.
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Further, we would likely become a “penny stock”, which would make trading of our common stock more difficult.
−Removed: We will require additional financing in the near term, which financing may result in the reduction of the exercise price of certain of our warrants.
+Added: We will require additional financing in the near term, which financing may result in the reduction of the exercise price of the Series I warrants that we issued in our August 2026 Offering.
Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive.
We will require substantial additional future capital in order to complete clinical development and commercialize Annamycin.
−Removed: Our Series G warrants and Series H warrants, which combined represent the potential issuance of 8,978,779 shares of common stock, provide that if, while such warrants are outstanding, we sell any common stock and/or common stock equivalents other than in connection with certain exempt issuances, at a purchase price per share less than the exercise price of the warrants in effect immediately prior to such sale, then immediately after such sale the exercise price of the Series G warrants and/or Series H warrants then in effect will be reduced to an amount equal to the new issuance price, subject to floor prices of $1.326 and $0.962, respectively.
−Removed: UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
−Removed: Other than as previously disclosed in our Current Report on Form 8-K on February 20, 2026 , we did not sell any unregistered equity securities during the fiscal quarter ended March 31, 2026 .
−Removed: DEFAULTS UPON SENIOR SECURITIES
−Removed: MINE SAFETY DISCLOSURE
−Removed: Not applicable.
+Added: The Series I warrants that we issued in the August 2026 Offering provide that if, while the Series I warrants are outstanding, we sell any common stock and/or common stock equivalents other than in connection with certain exempt issuances, at a purchase price per share less than the exercise price of the Series I warrants in effect immediately prior to such sale, then immediately after such sale the exercise price of the Series I warrants then in effect will be reduced to an amount equal to the new issuance price, subject to a floor price of $0.21 per share.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.